ndercarboxylated osteocalcin, the hypothalamic-pituitary-gonadal axis and glucose metabolism in male patients with osteoporosis.
Withdrawn
- Conditions
- Osteoporosis100184241000595910018515
- Registration Number
- NL-OMON36967
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Male sex
50-80 years
Recently diagnosed primary osteoporosis
Testosterone within reference range
Exclusion Criteria
Contraindication to parathyroid hormone therapy: hypersensitivity to the active substrate or to any of the excipients, pre-existing hypercalcaemia, hepatic- or renal insufficiency, metabolic bone diseases other than primary osteoporosis or glucocorticoid-induced osteoporosis, unexplained elevations of alkaline phosphatase, prior external beam or implant radiation therapy to the skeleton, patients with skeletal malignancies or bone metastases ;Any medication or disease influencing bone turnover
Diabetes mellitus
Hypogonadism
Inability to give informed consent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* undercarboxylated osteocalcin<br /><br>* testosterone concentrations<br /><br>* glucose tolerance determined by an oral glucose tolerance test<br /><br>* insulin sensitivity determined by a hyperinsulinemic euglycemic clamp<br /><br>* changes in body composition by a whole-body DXA scan<br /><br><br /><br>All patients will be studied at baseline and after 6 and 12 weeks of<br /><br>intervention. Patients will serve as their own controls.</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>